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Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.

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ClinicalTrials.gov Identifier: NCT00260247
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Danish Research Agency
Novartis
Information provided by:
Odense University Hospital

Study Description
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Brief Summary:

This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.

This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.

It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.


Condition or disease Intervention/treatment Phase
Metabolic Clearance Rate Drug: carbamazepine oxcarbazepine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
Study Start Date : April 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Formation clearance of 3-hydroxyquinidine

Secondary Outcome Measures :
  1. Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI < 30
  • Non smoker
  • No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
  • Informed consent

Exclusion Criteria:

  • signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
  • mental disease
  • participation in another clinical trial involving drugs with 3 months of randomization
  • donation of more than 500 mL blood within 3 months of randomization
  • intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260247


Locations
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Denmark
University of Southern Denmark
Odense, Denmark, 5210
Sponsors and Collaborators
Odense University Hospital
Danish Research Agency
Novartis
Investigators
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Principal Investigator: Per Damkier, MD, Ph.D. Odense University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00260247    
Other Study ID Numbers: AKF-315
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: March 2005
Keywords provided by Odense University Hospital:
CYP3A4
Induction
Oxcarbazepine
Carbamazepine
 Quinidine
Human
In vivo
Additional relevant MeSH terms:
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Carbamazepine
Oxcarbazepine
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Voltage-Gated Sodium Channel Blockers